Telix Pharmaceuticals Limited (TLX), a biopharmaceutical company, announced that the United Kingdom Medicines and Healthcare Products Regulatory Agency or MHRA has granted marketing authorization for its prostate cancer imaging agent, Illuccix.
Illuccix has been approved for use in the detection and localization of prostate-specific membrane antigen or PSMA-positive lesions in adults with prostate cancer, utilizing PET imaging.
The approval marks a significant advancement in prostate cancer management, as PSMA-PET imaging has been replacing conventional methods such as bone scans and CT scans as the standard of care after initial diagnosis and biochemical recurrence.
The approval comes as PSMA-PET imaging supply shortages in the UK and Europe have escalated, leading to delays for patients in need of urgent scans.
Telix aims to address this unmet need by expanding access to Illuccix through its exclusive distribution partner, Xiel Limited.
Raphaël Ortiz, CEO of Telix International, expressed his excitement about the approval, stating, "PSMA-PET imaging is one of the most important developments in prostate cancer detection in recent years, and we are thrilled to bring Illuccix to physicians and patients across the UK."
Illuccix received approval from the FDA in the U.S in December 2021, from the TGA in Australia in November 2021, and from Health Canada in October 2022.
The revenue from Illuccix sales in the United States for the third quarter of 2024, was roughly US$131 million (AU$195 million).
The company is slated to release its full year 2024 results on Feb.20, 2025.
TLX closed Wednesday's (Feb.12 2025) trading at $17.60 down by 0.11%. In premarket trading Thursday, the stock is down by 3.09% at $17.25.
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